Methods for asymmetrical irradiation of a body cavity

ABSTRACT

The disclosure describes devices and methods for asymmetrical irradiation at a body cavity or site, such as after removal of tissue, e.g. biopsy or cancer. One device includes a lumen which is off-set or off-settable from a longitudinal axis to increase the intensity of radiation received from a radiation source by a first tissue portion surrounding the body cavity and to reduce or minimize radiation received by a second tissue portion (e.g. healthy tissue) surrounding the body cavity.

RELATED APPLICATIONS

This application is related to and claims priority from provisionalapplication Ser. No. 60/819,919 filed on Jul. 11, 2006, entitledRadiation Device For A Body Cavity which is incorporated herein byreference.

FIELD OF THE INVENTION

This invention relates generally to the fields of medical treatmentdevices and methods. In particular, the invention relates to devices andmethods for treating tissue surrounding a body cavity, such as a sitefrom which cancerous, pre-cancerous, or other tissue has been removed.

BACKGROUND OF THE INVENTION

In diagnosing and treating certain medical conditions, it is oftendesirable to perform a biopsy, in which a specimen or sample of tissueis removed for pathological examination, tests and analysis. A biopsytypically results in a biopsy cavity occupying the space formerlyoccupied by the tissue that was removed. As is known, obtaining a tissuesample by biopsy and the subsequent examination are typically employedin the diagnosis of cancers and other malignant tumors, or to confirmthat a suspected lesion or tumor is not malignant. Treatment of cancersidentified by biopsy may include subsequent removal of tissuesurrounding the biopsy site, leaving an enlarged cavity in the patient'sbody. Cancerous tissue is often treated by application of radiation, bychemotherapy, or by thermal treatment (e.g., local heating, cryogenictherapy, and other treatments to heat, cool, or freeze tissue).

Cancer treatment may be directed to a natural cavity, or to a cavity ina patient's body from which tissue has been removed, typically followingremoval of cancerous tissue during a biopsy or surgical procedure. Forexample, U.S. Pat. No. 6,923,754 to Lubock and U.S. patent applicationSer. No. 10/849,410 to Lubock, the disclosures of which are all herebyincorporated by reference in their entireties, describe devices forimplantation into a cavity resulting from the removal of canceroustissue which can be used to deliver cancer treatments to surroundingtissue. One form of radiation treatment used to treat cancer near a bodycavity remaining following removal of tissue is “brachytherapy” in whicha source of radiation is placed near to the site to be treated.

Lubock above describes implantable devices for treating tissuesurrounding a cavity left by surgical removal of cancerous or othertissue that includes an inflatable balloon constructed for placement inthe cavity. Such devices may be used to apply one or more of radiationtherapy, chemotherapy, and thermal therapy to the tissue surrounding thecavity from which the tissue was removed. The delivery lumen of thedevice may receive a solid or a liquid radiation source. Radiationtreatment is applied to tissue adjacent the balloon of the device byplacing radioactive material such as radioactive “seeds” in a deliverylumen. Such treatments may be repeated if desired.

For example, a “MammoSite® Radiation Therapy System” (MammoSite® RTS,Proxima Therapeutics, Inc., Alpharetta, Ga. 30005 USA) includes aballoon catheter with a radiation source that can be placed within atumor resection cavity in a breast after a lumpectomy. It can deliver aprescribed dose of radiation from inside the tumor resection cavity tothe tissue surrounding the original tumor. The radiation source istypically a solid radiation source; however, a liquid radiation sourcemay also be used with a balloon catheter placed within a body cavity(e.g., Iotrex®, Proxima Therapeutics, Inc.). A radiation source such asa miniature or micro-miniature x-ray tube may also be used (e.g. U.S.Pat. No. 6,319,188). The x-ray tubes are small, flexible and arebelieved to be maneuverable enough to reach the desired treatmentlocation within a patient's body. The radiation source is to be removedfollowing each treatment session, or remains in place as long as theballoon remains within the body cavity. Inflatable treatment deliverydevices and systems, such as the MammoSite® RTS and similar devices andsystems (e.g., GliaSite® RTS (Proxima Therapeutics, Inc.)), are usefulto treat cancer in tissue adjacent a body cavity.

However, radiation, chemotherapy, thermal treatment, and other cancertreatments often have deleterious effects on healthy tissue in additionto the desired effects on cancerous tissue. In such treatments, caremust be taken to direct the maximum treatment effects to diseased tissuewhile minimizing its delivery or effects on healthy tissue. For example,radiation treatment may be most effective when only the portion oftissue requiring treatment receives the radiation and where surroundinghealthy tissue is unaffected. Tissue cavities typically are not uniformor regular in their sizes and shapes, so that differences in dosagesapplied to different regions of surrounding tissue, including “hotspots” and regions of relatively low dosage, often result from radiationtreatment.

A treatment delivery device for treating tissue adjacent a body cavityhas been disclosed in U.S. Pat. No. 6,923,754. This device applies apartial-vacuum or suction to bring tissue towards a radiation source andallows for uniform application of radiation to tissue surrounding a bodycavity. An advantage of the present invention is that it allows for theprotection of healthy tissue within that body cavity and provides a sealin the passageway leading to the body cavity while treating the desiredtissue.

SUMMARY OF THE INVENTION

This invention is generally directed to treating a patient's body cavityor other intracorporeal site (hereinafter collectively referred to as abody cavity) and devices and methods for such treatments. The inventionis particularly suitable for treating tissue adjacent to a body cavityformed by the removal of tissue such as in a biopsy or lumpectomy.

More specifically, a device embodying features of the invention has adistal portion with a treatment location which is configured to beasymmetrically deployed within the body cavity so as to be closer to afirst portion of tissue surrounding the cavity than a second portion oftissue surrounding the cavity opposite the first tissue portion. Thetreatment location of the distal portion which includes or is configuredto receive a radiation source such as a brachytherapy seed or otherirradiating agent for irradiating the first portion of tissuesurrounding the body cavity more intensely that the second portion oftissue surrounding the body cavity opposed to the first portion oftissue due to the radiation source being closer to the first tissueportion than to the second tissue portion.

In one embodiment the treatment location having a radiation source isoffset or capable of being offset within the body cavity so that tissueof the first portion of the cavity receives more intense radiationtreatment than the tissue of the second portion.

This invention is generally directed to treating a patient's body cavityor other intracorporeal site and devices and methods for suchtreatments. The invention is particularly suitable for treating tissueadjacent to a body cavity such as a cavity formed by the removal oftissue.

More specifically, a device embodying features of the invention has adistal portion with a treatment location which is configured to beasymmetrically deployed within the body cavity and which is configuredto receive or which includes a brachytherapy or other irradiating agentfor treating tissue surrounding the cavity or other site.

In one embodiment the treatment location having a radiation source isoffset or capable of being offset from the central location within thebody cavity so that tissue of one portion of the cavity receives moreintense radiation treatment than the tissue of an opposing portion.

The invention is generally directed to treating a patient's body cavityby irradiation, and devices and methods for such treatments. Theinvention is particularly suitable for treating tissue adjacent apatient's body cavity, such as that formed by removal of tissue for abiopsy.

More specifically, a device embodying features of the invention includesa treatment location at a distal portion of the device which isconfigured to receive or which includes a brachytherapy agent, such as aradiation source and which has a centrally located longitudinal axis.The distal portion of the shaft with the treatment location isdeployable within the body cavity so as to provide asymmetricaltreatment such as irradiation thereto to tissue surrounding the cavityand is or is capable of being deployed away from the longitudinal axisand closer to one portion of the cavity than an opposed portion.

In one embodiment the distal portion of the device has at least onedelivery lumen which is configured to receive a radiation source andwhich is off-set or capable of being off-set from a central longitudinalaxis so that the radiation source is closer to the tissue of the firstportion of the body cavity than the tissue of the second portion of thecavity at an opposing side resulting in greater levels of radiationbeing received by the first tissue portion of the cavity. In thisembodiment the device may also have one or more radiation shieldingcomponents that provide further control of the radiation emitted fromthe radiation source, such as described in concurrently filedapplication Ser. No. ______, entitled Tissue Irradiation With Shielding.Off-setting the lumen in which the radiation source is deployed placesthe radiation source closer to a first tissue portion surrounding thebody cavity to provide greater levels of radiation thereto and furtheraway from the second tissue portion surrounding the body cavity at otherlocations to reduce the level of radiation thereto. The radiationreceived by the tissue surrounding the body cavity is a function ofinverse of the distance (R) from the radiation source squared (1/R²), soeven small changes in the location of the radiation source within a bodycavity can make a significant impact on the amount of radiation receivedby tissue in the body cavity or site. In this embodiment the shafthaving the distal portion with the treatment location may be deformed todeflect the radiation lumen to an off set location with respect to thecentral longitudinal axis. An alternative is to provide an asymmetricalcavity filling member that holds the distal portion of the shaft withthe treatment location at a desired position within the cavity or bodysite to provide asymmetrical irradiation to the tissue surrounding thecavity or site. This may be accomplished with a cavity filling memberthat is asymmetrical, is mounted asymmetrically on the shaft or isconfigured to be inflated to an asymmetrical shape. The cavity fillingmember may have separate chambers which are independently inflated todifferent sizes so as to develop an asymmetrical shape that results inan off-set of the radiation source.

In another embodiment the device has an outer sheath with an inner lumenand an inner cannula or catheter which is rotatably disposed within theinner lumen of the outer sheath. The cannula or catheter has an innerlumen which is configured to receive a radiation source. The inner lumenreceiving the radiation source is off set from a central longitudinalaxis of the catheter or cannula, so that rotation of the cannula orcatheter within the inner lumen of the outer sheath will adjust theposition of a radiation source within the body cavity or site to providethe desired asymmetrical irradiation dose within the cavity.

The elongated shaft may also have one or more radiation shieldingcomponents designed to reduce or minimize damaging irradiation ofhealthy tissue surrounding the body cavity while treating nearby areashaving diseased tissue with radiation emitted from the radiation source.The radiation shielding components include one or more radiation shieldsdisposed about a delivery shaft containing the radiation source.Suitable radiation shielding components are describe is co-pendingapplication Ser. No. ______, filed concurrently herewith, entitledTissue Irradiation With Shielding.

A device embodying features of the invention preferably has an enlargedor enlargeable cavity filling member at the treatment location which atleast in part fills the body cavity. Preferably, the cavity fillingmember is inflatable member such as a balloon. The elongated shaft hasan inner inflation lumen for directing inflation fluid to the interiorof the cavity filling member for its inflation.

The device may also include an inner lumen configured to be in fluidcommunication with a proximal vacuum source and one or more vacuum portspreferably proximal and or distal to the cavity filling member such asdescribed in U.S. Pat. No. 6,923,754 and co-pending application Ser. No.10/849,410 filed on May 19, 2004, both of which are assigned to thepresent assignee. Application of a vacuum within the inner lumenaspirates fluid in the cavity through one or more vacuum ports and thevacuum within the body cavity pulls tissue defining the cavity onto theexterior of the cavity filling member deployed within the cavity. Theapplication of a vacuum may also be employed to aspirate fluids from thecavity or site.

A method for treating a body cavity or other intracorporeal site of apatient includes delivering a treatment agent such as a radiation sourceto a body cavity to treat the desired tissue while minimizing damagingirradiation of healthy tissues. More specifically, a method for treatinga body cavity or intracorporeal site includes providing a device havingan elongate shaft with a proximal end, a distal end, and a treatmentlocation in a distal portion of the shaft. The method further includesproviding a radiation source configured to be deposited in the treatmentlocation and a radiation shielding component partially encircling thetreatment location which is configured to control at least in part theemission of radiation emitted from the treatment location. The device isadvanced within the patient until the treatment location of the deviceis deployed within the body cavity or site and the radiation source ispositioned within the treatment location. The radiation shieldingcomponent is positioned to shield portions of the body cavity fromradiation emitted from the radiation source.

A patient's skin is susceptible to damage from radiation delivered byisotopes (e.g. seeds) or x-ray catheters in a lumen of a radiationballoon catheter if the radiation source is to close to the skin.Generally, radiation treatments using a radiation balloon catheter isusually not performed on patients where the body cavity (e.g. from alumpectomy) is less than 5 mm, sometimes less than 7 mm from thepatient's skin. Additionally, over inflation of the balloon can thin andstretch the skin. The application of a vacuum to the body cavity canhelp by pulling the tissue to the balloon and increased cavity to skinsurface distances would result. However, in some instances it wouldstill be too thin to treat. The number of potential patient's which aresuitable candidates for treatments with the present device issignificantly increased due to reducing the potential for skin tissuedamage.

Placing patterns of radiation absorbing materials on the surface orwithin the wall of the balloon would aid in shielding the skin or inother cases, sensitive organs (e.g., heart, lung, ribs, etc.) fromunnecessary radiation. Examples include—Mylar with aluminum, ballooncoatings with gold, lead, titanium barium and barium sulfate or silverions incorporated within the balloon wall.

The surface (inside or outside) of the balloon or within the balloonwall may be provided with indicator marks for location or orientationdetection during the procedures. For example, dots or lines to helpplace balloon in appropriate position under CT, x-ray or fluoroscopy.The indicator marks may be radiopaque. Alternatively, or additionally,ultrasound indicators or MRI and direct visual indicators could beincorporated. The indicator marks may extend along the catheter shaft tohelp with placement of the catheter device during the treatmentprocedure and the orientation of the off set lumen and shield.

In other embodiments having features of the invention, the radiationshield may be secured to a control rod or band within the catheterdevice so that the location of the shield may be adjusted.Alternatively, the radiation shield may be secured within or onto thecatheter device.

These and other advantages of the present invention are described inmore detail in the following written description and the accompanyingexemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view, partially in section, of a brachytherapydevice embodying features of the invention including a cavity fillingmember.

FIG. 2 is a transverse cross sectional view of the device shown in FIG.1 taken along lines 2-2 which illustrates the device with two innerlumens.

FIG. 3 is a transverse cross sectional view of an alternative devicesimilar to the device shown in FIG. 1 having three lumens.

FIG. 4 is a transverse cross sectional view of an alternative devicesimilar to the device shown in FIG. 1 having 5 lumens.

FIG. 5 is a transverse cross-sectional view of an alternative devicehaving three lumens having circular transverse cross-sections and a pairof opposed arcuate inner lumens for radiation shielding component.

FIG. 6 is a transverse cross-sectional view of a device similar to thatshown in FIG. 1 which has a plurality of arcuate lumens with enlargedcentral portions which allow for the deployment of a radiation shield ora radiation source within the lumens.

FIG. 7 is an elevational view, partially in section, of a distal portionof an alternative design for a brachytherapy device wherein the shaftwithin the cavity filing member is deformed to place the radiationsource closer to one side of the cavity filling member than an opposedsite.

FIG. 7A is an enlarged longitudinal cross-section of the deformed shaftwithin the cavity filling member.

FIG. 8 is a transverse cross-sectional view of the device shown in FIG.7 taken along the lines 8-8.

FIG. 9 is an elevational view of a distal portion of an alternativedesign for a brachytherapy device wherein the cavity filling member isasymmetric, or inflated to an asymmetric configuration to place theradiation source closer to one side of the body cavity or site.

FIG. 10 is a transverse cross-sectional view of the brachytherapy deviceshown in FIG. 9 taken along the lines 10-10.

FIG. 11 is a transverse cross-sectional view similar to that shown inFIG. 10 in which the interior of the cavity filling member is separatedinto two chambers by a membrane so that each chamber may be inflated,e.g. to different sizes.

FIG. 12 illustrates a shaft formed of a plurality of elongated elementswith at least one of the elongated elements having an inner lumenconfigured to receive a radiation source.

FIGS. 13A-B illustrate another embodiment having features of theinvention which has an outer catheter with a cavity filling member andan inner catheter with an inner lumen which is off set or off settablefrom a longitudinal axis.

FIG. 14A is a perspective view, partially in section, of an alternativedevice which has a plurality of radially extending tubular members fordelivery of radiation sources.

FIG. 14B is a transverse cross-sectional view of the device shown inFIG. 14A taken along the lines 14B-14B.

FIG. 14C is a perspective view of a compartmented support member andtubular members which extend through an inflatable member.

FIG. 14D is a transverse cross-sectional view of the device shown inFIG. 14A taken along the lines 14D-14D.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to devices and methods for treatmentof a patient's body cavity, particularly to deliver asymmetricalradiation into a biopsy cavity or into a cavity left after removal oftissue from the patient's body. Other body sites may also be treated.

FIGS. 1 and 2 illustrate a brachytherapy device 10 embodying features ofthe invention which has an elongated shaft 11 with a treatment location12 in a distal portion 13 of the elongate shaft 11. The shaft 11 has afirst lumen 14 which is off set from central longitudinal axis 15 andwhich is configured to receive a radiation source 16. The radiationsource 16 is disposed at the distal end of pusher rod 17 to facilitatedeployment within the treatment location 12. The elongate shaft 11 alsohas a second lumen 18 for delivery of inflation fluid to the interior ofthe cavity filling member 19 through inflation port 20. The elongatedshaft 11 may also have a third lumen 21 shown in phantom to provide avacuum to a desired location such as vacuum ports 22 and 23 also shownin phantom which are proximal and/or distal to the cavity filling member19 as described in U.S. Pat. No. 6,923,641 (assigned to the presentassignee). The third lumen may also be utilized as an off-set lumen toreceive a radiation source in the event the first lumen 14 is not in adesired location when the distal end of the device is placed in thepatient and the physician does not wish to rotate the device 10. Theproximal end of the shaft 11 has a multi-arm adapter 24 for delivery ofa vacuum, inflation fluid and radiation source as shown. The device 10may also have one or more radiation shielding components (not shown) tofurther reduce radiation to tissue which is not to be treated. Suitableradiation shielding components are described in co-pending applicationSer. No. ______, filed concurrently herewith entitled Tissue IrradiationWith Shielding which has been assigned to the present assignee.

A body cavity within a patient may be treated with the device 10 byinserting the distal shaft portion 13 into the desired body cavity withthe off-set first lumen 14 configured to receive the radiation source 16being closer to a first tissue portion surrounding the cavity to betreated and farther away from a second tissue portion surrounding thecavity which needs to be protected. A radiation source 16 is advancedwithin the first lumen 14 until the radiation source is properlypositioned within the treatment location 12 (or prepositioned therein).Inflation fluid is delivered to the interior of the cavity fillingmember 19 so as to at least partially fill the body cavity. A vacuum maybe generated about the cavity filling member 19 through vacuum ports 22and 23 to conform the tissue surrounding the cavity to the exterior ofthe cavity filling member. The radiation source 16 is maintained at thetreatment location 12 for a prescribe period of time, usually less than30 minutes and typically a few (5-10) minutes. At the end of thetreatment time the radiation source may be removed from device 10 or theentire device may be withdrawn from the patient. Preferably, the deviceis left in place so that further radiation treatments may be performed.

FIG. 3 illustrates an elongated shaft 11 a of an alternativebrachytherapy device which has three off-set lumens 25, 26 and 27 thatare equally disposed about the longitudinal axis 28. The first off-setlumen 25 may be used as the radiation delivery lumen such as describedabove for first lumen 14. The second and third off-set lumens 26 and 27may be utilized for delivery of inflation fluid to the interior of acavity filling member (not shown) or for delivery of a vacuum to vacuumports (not shown) proximal or distal to the cavity filling member asdescribed above. Additionally, a centrally located fourth lumen 29(shown in phantom) may be provided as an alternative lumen for radiationdelivery in the event an off-set location is not needed. The fourthlumen may also be employed as an inflation or vacuum lumen as describedabove, leaving one of the off-set lumens 26 and 27 to deliver aradiation source in the event the first off-set lumen is not in adesirable location when the device is deployed within the patient's bodycavity.

FIG. 4 illustrates an elongated shaft 11 b of another alternative designof device 10 which has four off set lumens 30-33, one central lumen 34which is axially aligned with longitudinal axis 35. The off set lumens30-33 and central lumen 34 may be utilized as in the prior embodiments.This embodiment provides additional alternative lumens for delivery of aradiation source (not shown) as described above.

FIG. 5 illustrates yet another elongated shaft 11 c of an alternativedesign which has two off set lumens 36 and 37 and a central lumen 38which have circular transverse cross-sections as shown. The off set andcentral lumens 36, 37 and 38 may be utilized as described above.Additionally, at least one arcuate lumen 39 may be provided tofacilitate placement of a radiation shield 40 as described inconcurrently filed application entitled Shielding of a Radiation Devicefor a Body Cavity. A second arcuate lumen 41 at an opposed positionwithin the shaft 11 c (shown in phantom) for delivery of a radiationshield in the event the device is not placed in a desired orientationand the physician does not want to rotate the device.

FIG. 6 depicts another elongated shaft 11 d for an alternativebrachytherapy device 10 which has a first arcuate lumen 42 with anenlarged central portion 43. This first arcuate lumen 42 is design toslidably receive a radiation shielding member 44 and the enlargedcentral portion 43 is designed to slidably receive a radiation source 45such as shown in second arcuate lumen 46 with enlarged central portion47. A central lumen 48 is axially disposed about the longitudinal axis49 and may be utilized for delivery of inflation fluid or a vacuum tothe distal portion of the device. This design allows for the flexibilityof placing either a radiation source or a radiation shielding member oneither side of the device. The central lumen 48 may alternatively bepositioned off-set within the shaft 11 d. Other off-set lumens may beprovided as described above with respect to the other embodiments.

FIGS. 7, 7A and 8 depict an alternative brachytherapy device 50 whichhas an elongated shaft 51 with a treatment location 52 in a distalportion 53 thereof. The shaft 51 is deformable within the treatmentlocation 52. The elongated shaft 51 has a first lumen 54 which isconfigured to receive a radiation source 55 to position a radiationsource off set from the longitudinal axis 56. The radiation source 55has a standard pusher rod 57 to facilitate placement of the radiationsource at the treatment location 52 within the first lumen 54. Thedistal shaft portion 53 is deformed, i.e. radially deflected, bypull-wire 58 so that the treatment location 52 is off-set or further offset from the longitudinal axis 56. The distal end of the pull-wire 58has an enlarged hub which secures the distal end of the pull-wire withinthe shaft. The deformation of the distal shaft portion 53 places theradiation source 55 closer to one side of the cavity filling member 60thereby reducing the radiation to tissue of the opposing side of thecavity. While only one pull-wire 58 is illustrated, multiple pull-wiresmay be employed about the longitudinal axis 56 to facilitate deformationof the distal shaft portion 53 in multiple directions. Other mechanicalstructures, may be provided to radially deflect the distal shaft portion53 away from longitudinal axis 56. Off-set lumen 61 leads to inflationport 62 for directing inflation fluid to the interior of the cavityfilling member 60. Off-set lumen 63 leads to vacuum port 64 (shown inphantom) proximal to the cavity filling member 60 to generate a vacuumwithin the body cavity to aspirate fluids and/or to conform surroundingtissue of the body cavity to the exterior of the cavity filling member60.

FIGS. 9 and 10 illustrate another brachytherapy device 70 embodyingfeatures of the invention. The device 70 has an elongated shaft 71, atreatment location 72 in distal shaft portion 73, a first lumen 74configured to receive radiation source 76, a second lumen 77 and a thirdlumen 78 and an asymmetrical cavity filling member 80. The first lumen74 is closest to the smaller side 81 of the cavity filling member 80 sothat radiation through the smaller side 81 of the cavity filling member80 to adjacent tissue is greater than the radiation through the largerside 82 to adjacent tissue. The larger side 82 of the cavity fillingmember 80 is placed next to tissue in which the radiation dose is to beminimized, whereas the smaller side 81 is positioned adjacent to tissuewhich is to receive a higher dose of radiation. The second and thirdlumens 77 and 78 may be utilized for vacuum and inflation fluid asdiscussed above with respect to other embodiments.

FIG. 11 shows an alternative brachytherapy device 90 which has anelongated shaft 91 with three inner lumens. Off set lumens 92 and 93 andcentrally disposed lumen 94. The first off set lumen 92 is for receivinga radiation source as previously described. The second off set lumen 93may be for vacuum, inflation fluid or as an alternative lumen for aradiation source. The central lumen 94 may be employed for vacuum,inflation fluid or alternatively a radiation source. The device 90 has acavity filling member 95 which has inner membranes 96 and 97 whichseparate the interior of the cavity filling member into separatechambers 98 and 99. Each chamber has separate sources (lumens) forinflation fluid so that one side 100 of the cavity filling member 95 maybe inflated to one or more different sizes than an adjacent side 101. Asshown in phantom, the side 100 may be inflated to a smaller size 100 aor a larger size 100 b. Adjusting the sizes controls the location of theradiation source within a lumen. With a smaller size 100 a, the tissueto be treated adjacent to side 100 receives a higher radiation dose thantissue adjacent to side 101 which should be protected and given asmaller radiation dose. Alternatively, when chamber 98 is inflated sothat side 100 is of a larger size, the tissue adjacent to side 100 willreceive more radiation.

FIG. 12 depicts an elongate shaft 11 e of an alternative device whichcomprises a plurality of elongated tubular elements 110, 111, 112 and113. At least one of the elongated elements 110 has a first inner lumen114 configured for receiving a radiation source such as described abovefor the other embodiments. The other elongated elements may also haveinner lumens 115-117 for delivery of inflation fluid to a cavity fillingmember (not shown) on a distal portion of the shaft, for delivery of avacuum to a vacuum port proximal or distal to the cavity filling memberor an additional lumen for receiving a radiation source. The pluralityof elements 110-113 may be bundled together by one or more outer strapsor bands or by an outer sheath or by a suitable adhesive. The pluralityof elongated elements of the shaft may be twisted or braided together.Tubular element 110 (as well as 111-113) may be radially deflected asdepicted in FIG. 7 to position the first inner lumen closer to the firsttissue portion surrounding the body cavity than the second tissueportion.

FIGS. 13A-B illustrate a brachytherapy device 120 which has an outercatheter 121 with an inner lumen 122 and an inner catheter 123 which isconfigured to be rotatably disposed within the inner lumen 122. Theouter catheter 121 has an inflatable cavity filling member 124 on adistal portion 125 of shaft 126. The wall of shaft 126 has at least onelumen 127 for directing inflation fluid to the interior of the cavityfilling member 124. The outer catheter 121 also has vacuum ports 128 and129 proximal and distal to the cavity filling member 124. The wall 130of shaft 126 has at least one lumen 131 which is in fluid communicationwith a vacuum port and preferably two lumens. The inner catheter 123 hasan elongated shaft 132 with an off-set lumen 133 and may also have acentral lumen 134 configured for receiving a radiation source to providean asymmetrical radiation dose about longitudinal axis 135.

FIGS. 14A-14D illustrate an alternative device 140 which has anelongated shaft 141, a cavity filling balloon 142 on the distal portionof the shaft and an adapter 143 on the proximal end of shaft 141. Aplurality of tubes 144-148 extend into the adapter 143 and are in fluidcommunication with lumens 150-154 respectively within the shaft 141which are configured to receive radiation sources (not shown) such asthose previously described. The device 140 also has an inflation tube149 which is in fluid communication with lumen 155 that extends to andis in fluid communication with the interior of the balloon 142 tofacilitate delivery of inflation fluid thereto. The adapter 143 has avacuum arm 156 that is in fluid communication with lumens 157 and 158.Lumen 158 is in fluid communication with proximal vacuum port 160 andlumen 157 is in fluid communication with tubular member 161 which inturn is in fluid communication with distal vacuum port 162. Radiationdelivery tubes 163-167 are in fluid communication with lumens 150-154.Radiation tube 163 and 164 are radially extended within the interior ofballoon 142 in order to be closer to a first tissue portion surroundinga body cavity as previously described. While tubes 163 and 164 are shownas being radially extended within the balloon 142, one radiationdelivery tube or more than two radiation delivery tubes may radiallyextend within the balloon 142 depending upon the need for a particulartreatment.

A compartmented support element 168 extends between the proximal anddistal ends of the balloon 142. The support element 168 shown has ninecompartments 170-174 which are designed to receive tubular radiationdelivery members 163-167 respectively. The device 140 may be assembledwith the radial extension of radiation delivery tubes 144 and 145 fixedas shown or they may be slidable within the catheter shaft 141 so thatthe radial extension of these delivery tube be effected during theprocedure. The radial extension of the radiation delivery tubes will notusually extend to contact the interior surface of the inflated balloon142.

The radiation delivery tubes 144-148, which extend into the adapter 143,may extend through the lumens in shaft 141 and may form tubes 163-167which are received by the support member 163.

All of the radiation delivery tubes which extend through the interior ofthe balloon 142 would not necessarily be used in a procedure and in factwould probable not be used. However, they would be available for use bythe physician if needed, e.g. when the catheter is not in a desiredposition and rotation of the catheter is not appropriate or desirable.The shaft 141 is shown as a solid shaft having a plurality ofpassageways. However, the shaft 141 may be made more flexible byutilizing a plurality of tubes which are bundled together form the shaftas shown in FIG. 12.

The radiation source 16 for the brachytherapy device 10 can include asolid or liquid radiation source. Suitable liquid radiation sourcesinclude, for example, a liquid containing a radioactive iodine isotope(e.g., I¹²⁵ or I¹³¹), a slurry of a solid isotope, for example, ¹⁹⁸Au or¹⁶⁹Yb, or a gel containing a radioactive isotope. Liquid radiationsources are commercially available (e.g., Iotrex®, Proxima Therapeutics,Inc., Alpharetta, Ga.). The radiation source 16 preferably includesbrachytherapy seeds or other solid radiation sources used in radiationtherapy, for example, a radioactive microsphere available from 3MCompany of St. Paul, Minn. Microminiature x-ray source may also beutilized. The radiation source 16 may be either preloaded into thedevice 10 at the time of manufacture or may be loaded into the device 10before or after placement into a body cavity or other site of a patient.Solid radionuclides suitable for use with a device 10 embodying featuresof the present invention are currently generally available asbrachytherapy radiation sources (e.g., I-Plant.®. Med-Tec, Orange City,Iowa.). Radiation may also be delivered by a device such as the x-raytube of U.S. Pat. No. 6,319,188. The x-ray tubes are small, flexible andare believed to be capable of being maneuverable enough to reach thedesired location within a patient's body.

The brachytherapy device 10 having features of the invention can beprovided with a lubricious coating, such as a hydrophilic material. Thelubricious coating preferably is applied to the elongate shaft 12 or tothe cavity filling member, if one is present, or both to reduce stickingand friction during insertion of a device 10. Hydrophilic coatings suchas those provided by AST, Surmodics, TUA Systems, Hydromer, or STSBiopolymers are suitable.

A device 10 having features of the invention may also include anantimicrobial coating that covers all or a portion of the device 10 tominimize the risk of introducing of an infection during extendedtreatments. The antimicrobial coating preferably is comprised of silverions impregnated into a hydrophilic carrier. Alternatively the silverions are implanted onto the surface of the device 10 by ion beamdeposition. The antimicrobial coating preferably is comprised of anantiseptic or disinfectant such as chlorhexadiene, benzyl chloride orother suitable biocompatible antimicrobial materials impregnated intohydrophilic coatings. Antimicrobial coatings such as those provided bySpire, AST, Algon, Surfacine, Ion Fusion, or Bacterin Internationalwould be suitable. Alternatively a cuff member covered with theantimicrobial coating is provided on the elongated shaft of the deliverydevice 10 at the point where the device 10 enters the skin.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. Some details of thebrachytherapy devices have not been disclosed such as adaptors on theproximal ends of the shaft of the devices to provide access to theindividual lumens within the shaft. Further details may be found incopending application Serial No. filed concurrently herewith entitledShielding of a Radiation Device for a Body Cavity and U.S. Pat. No.6,955,641. To the extent not otherwise disclosed herein, materials andstructure may be of conventional design.

Moreover, individual features of embodiments of the invention may beshown in some drawings and not in others, but those skilled in the artwill recognize that individual features of one embodiment of theinvention can be combined with any or all the features of anotherembodiment. Accordingly, it is not intended that the invention belimited to the specific embodiments illustrated. It is thereforeintended that this invention be defined by the scope of the appendedclaims as broadly as the prior art will permit.

Terms such as “element”, “member”, “component”, “device”, “means”,“portion”, “section”, “steps” and words of similar import when usedherein shall not be construed as invoking the provisions of 35 U.S.C§112(6) unless the following claims expressly use the terms “means for”or “step for” followed by a particular function without reference to aspecific structure or a specific action. All patents and all patentapplications referred to above are hereby incorporated by reference intheir entirety.

1. An apparatus for treating tissue surrounding a body cavity of apatient with a radiation source, comprising: an elongate outer catheterhaving a distal end, a treatment portion proximal the distal end, and afirst lumen configured to extend into the treatment portion; and anelongate inner catheter positioned in the first lumen of the outercatheter, the elongate inner catheter having a longitudinal axis and anoff-set lumen off-set from the longitudinal axis, the elongate innercatheter being configured to extend within the first lumen into thetreatment portion of the elongate outer catheter and configured rotaterelative to the elongate outer catheter about the longitudinal axis, theoff-set lumen of the elongate inner catheter being configured to receivethe radiation source. 2-6. (canceled)
 7. The apparatus of claim 1,comprising an inflatable member coupled to the outer elongate catheterand positioned to surround the treatment portion.
 8. The apparatus ofclaim 7, wherein the elongate outer catheter has an annular wall and aninflation lumen located in the annular wall, the inflation lumen beingconfigured in fluid communication with an interior of the inflatablemember.
 9. The apparatus of claim 8, comprising: a first vacuum portlocated in the elongate outer cannula proximal to the inflatable memberand configured in fluid communication with a region exterior to theelongate outer cannula; and a first vacuum lumen located in the annularwall, and configured in fluid communication with the first vacuum port.10. The apparatus of claim 9, comprising: a second vacuum port locatedin the elongate outer cannula distal to the inflatable member andconfigured in fluid communication with the region exterior to theelongate outer cannula; and a second vacuum lumen located in the annularwall, and configured in fluid communication with the second vacuum port.11. The apparatus of claim 8, wherein the elongate inner catheterincludes a central lumen that extends along the longitudinal axis and isconfigured to receive the radiation source.
 12. A brachytherapy devicefor treating tissue surrounding a body cavity of a patient with aradiation source, comprising: an elongate outer catheter having a distalend, a treatment portion proximal the distal end, and a first lumenconfigured to extend into the treatment portion; and an elongate innercatheter positioned in the first lumen of the outer catheter, theelongate inner catheter having a longitudinal axis, a central lumen thatextends along the longitudinal axis, and an off-set lumen off-set fromthe longitudinal axis, each of the central lumen and the off-set lumenbeing configured to extend into the treatment portion in the outercatheter, and the elongate inner catheter configured rotate relative tothe elongate outer catheter about the longitudinal axis, each of thecentral lumen and the off-set lumen of the elongate inner catheter beingconfigured to receive the radiation source.
 13. The brachytherapy deviceof claim 12, comprising an inflatable member coupled to the outerelongate catheter and positioned to surround the treatment portion. 14.The brachytherapy device of claim 13, wherein the elongate outercatheter has an annular wall and an inflation lumen located in theannular wall, the inflation lumen being configured in fluidcommunication with an interior of the inflatable member.
 15. Thebrachytherapy device of claim 14, comprising: a first vacuum portlocated in the elongate outer cannula proximal to the inflatable memberand configured in fluid communication with a region exterior to theelongate outer cannula; and a first vacuum lumen located in the annularwall, and configured in fluid communication with the first vacuum port.16. The brachytherapy device of claim 15, comprising: a second vacuumport located in the elongate outer cannula distal to the inflatablemember and configured in fluid communication with the region exterior tothe elongate outer cannula; and a second vacuum lumen located in theannular wall, and configured in fluid communication with the secondvacuum port.